About Company:
Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company has 25 manufacturing and packaging facilities that are approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, Health Canada, South Africa MCC, Brazil ANVISA. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing CNS, Antiretroviral, CVS, Antibiotics, Gastroenterological, Anti-Diabetics and Anti-Allergic, supported by a strong R&D set-up.
Website
https://www.aurobindo.com/
Vacancy Details:
Job Description:
Greetings from Aurobindo Pharma Limited.
We are hiring RAD Professionals with experience in RAD US & Europe market for Apitoria Research Centre (100% subsidiary of Aurobindo Pharma Limited) in API Division for Hyderabad Cluster, Telangana, India.
Requirement details are mentioned below for your reference:
Qualification: MSc Chemistry
Experience: 2 – 6 Years experience in API-Regulatory Affairs
Department: Regulatory Affairs Department (RAD – API)
Designation: Executive / Senior Executive
Skill Set: Well versed in regulatory guidelines and filing requirements/ procedure. Expertise in eCTD handling. Good Communication & Interpersonal Skills with expertise in MS Office.
Job Description:
1.Responsible for new DMF submissions globally as per the market requirement.
2.Ensure to submit responses / Life Cycle Management.
3.Evaluation of Change Controls.
4.Responsible for New /revision of pharmacopeial monographs changes updating in DMFs / CEPs/ communication to CFTs and customers.
5.Smooth co-ordination with cross functional team (CFTs) to get the required data for regulatory submissions in timely manner.
6.Ensure to submit all pre/ post change notifications with appropriate documents / Sections to customers well in time.
7.Coordinating with marketing department / internal formulation for smooth regulatory filings in timely manner.
Please Note: Aurobindo Pharma Limited does not directly or indirectly charge any fees for job application or processing. Do not participate in any such invitations.
Interested and eligible candidates can apply through QR code.
